Wound Healing TimeCAP-HIPNCT07655388
Wound Healing, Dressing Type, and Dressing Change Frequency in THA
A study testing VACUTEX™ wound dressing and Octenisept® wound care dressing in people with Wound Healing Time and Total Hip Arthroplasty (THA), run by Clinical Center of Vojvodina at 1 site in Serbia.
Trial summary
Surgical wound complications following primary total hip arthroplasty remain a significant clinical challenge despite advances in wound care technologies. The optimal choice of dressing and frequency of dressing changes remain insufficiently investigated, particularly regarding their influence on wound healing and the… Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Wound Healing Time, Total Hip Arthroplasty (THA)
- What is being tested?
- VACUTEX™ wound dressing and Octenisept® wound care dressing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jul 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients scheduled for primary total hip arthroplasty (THA)
- Age ≥ 65 years
- Ability to provide informed consent
- Patients with closed surgical incision suitable for standard postoperative wound care
Who cannot join
- Revision hip arthroplasty
- Active infection at the time of surgery
- Immunosuppressive therapy or severe immunodeficiency
- Known allergy to dressing materials used in the study
- Severe peripheral vascular disease affecting wound healing
- Inability to comply with follow-up protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site, 1 recruiting
- Recruiting
Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina
Novi Sad, 21000
Nemanja Gvozdenović, PhD, Associate Professor, +381646355614, nemanja.gvozdenovic@mf.uns.ac.rs
About this study
Official title: Impact of Dressing Type and Dressing Change Frequency on Surgical Wound Healing Following Primary Total Hip Arthroplasty
Surgical wound complications following primary total hip arthroplasty remain a significant clinical challenge despite advances in wound care technologies. The optimal choice of dressing and frequency of dressing changes remain insufficiently investigated, particularly regarding their influence on wound healing and the wound microenvironment.
This prospective, randomized, controlled clinical trial aims to evaluate the impact of dressing type and dressing change frequency on surgical wound healing in patients undergoing primary total hip arthroplasty. Ninety patients will be allocated into three treatment groups receiving either a capillary-action dressing system (VACUTEX™) or standard dressings with different dressing change intervals.
The study will assess time to complete wound epithelialization, postoperative wound complications, pain intensity, wound temperature, exudate pH, length of hospital stay, and time to suture removal. In addition, the study will investigate the potential role of wound temperature and exudate pH as early indicators of impaired healing and postoperative complications.
Read the detailed description
This study will be designed as a prospective, randomized, controlled clinical trial conducted at the Clinic for Orthopedic Surgery and Traumatology, University Clinical Centre of Vojvodina. A total of 90 patients undergoing primary total hip arthroplasty will be enrolled and randomly allocated into three parallel treatment groups using block randomization.
The participants will receive one of the following wound care protocols:
Group 1: VACUTEX™ capillary-action dressing, changed every 4 days until suture removal.
Group 2: Standard dressing with Octenisept® aqueous solution, changed every 3 days until suture removal.
Group 3: Standard dressing with Octenisept® aqueous solution, changed every 2 days until suture removal.
Baseline demographic and clinical data, including age, sex, body mass index (BMI), comorbidities, smoking status, previous orthopedic procedures, and preoperative laboratory parameters (blood glucose, HbA1c, and C-reactive protein), will be collected at admission.
The primary outcome will be time to complete wound epithelialization, defined as the number of days from surgery to complete wound closure without exudate, dehiscence, signs of infection, or need for additional wound interventions.
Secondary outcomes will include:
Incidence of local postoperative wound complications (surgical site infection, dehiscence, seroma, and hematoma according to CDC criteria); Postoperative pain intensity assessed using the Visual Analogue Scale (VAS); Local wound temperature; Wound exudate pH; Length of hospital stay; Time to suture removal. Initial wound assessment will be performed immediately after wound closure in the operating room (postoperative day 0). Subsequent assessments will be conducted at each scheduled dressing change according to the assigned treatment protocol. Wound temperature will be measured using a non-contact infrared thermometer, while exudate pH will be determined using a calibrated digital pH meter. Pain intensity will be evaluated at each assessment using the VAS.
Participants will be followed throughout hospitalization and during outpatient visits up to 30 days after surgery. In cases of wound-related complications, follow-up will be extended up to 90 postoperative days.
Data will be recorded in standardized case report forms and entered into a dedicated database for statistical analysis. Statistical analyses will be performed using IBM SPSS Statistics software. Appropriate parametric and non-parametric tests, repeated-measures analyses, survival analysis (Kaplan-Meier and Cox regression), and multivariable regression models will be used according to the type and distribution of the collected data. A p-value <0.05 will be considered statistically significant.
- Conditions
- Wound Healing Time, Total Hip Arthroplasty (THA)
- Being tested
- VACUTEX™ wound dressing, Octenisept® wound care dressing
- Keywords
- Wound Dressing, VACUTEX, Dressing Change Frequency, Primary Total Hip Arthroplasty, Surgical Wound, Wound Healing, Exudate pH, Wound Temperature, Postoperative Pain, Orthopedic Surgery, Nursing, Surgical Site Infection, Epithelialization, Wound Care
- Medical subject headings
- Surgical Wound, Pain, Postoperative, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VACUTEX™ wound dressingDevice
A capillary action-based wound management system designed for continuous removal of exudate without the use of external negative pressure, maintaining a moist wound environment and minimizing dressing adherence to the wound surface.
Octenisept® wound care dressingProcedure or surgery
Standard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management.
| Study group | Role | What they receive |
|---|---|---|
| VACUTEX™ group | Experimental | Patients receive wound care using the VACUTEX™ capillary action dressing system with dressing changes performed every 4 days until wound closure (suture removal). Receives: Device: VACUTEX™ wound dressing |
| Standard dressing - 3-day change | Active comparator | Patients receive standard wound care using Octenisept® solution with sterile dressing, with dressing changes performed every 3 days until wound closure (suture removal). Receives: Procedure: Octenisept® wound care dressing |
| Standard dressing - 2-day change | Active comparator | Patients receive standard wound care using Octenisept® solution with sterile dressing, with dressing changes performed every 2 days until wound closure (suture removal). Receives: Procedure: Octenisept® wound care dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound epithelialization
Time (in days) from surgery to complete wound epithelialization, defined as complete clinical closure of the surgical incision without exudate, dehiscence, or visible wound gaps, as assessed by clinical examination.
Measured: Postoperative day 30 (90 or more in case of wound complications according to CDC criteria)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wound Healing TimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Center of Vojvodina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nemanja Gvozdenović, Clinical Center of Vojvodina
- Investigators
- Andrijana Ćorić, Principal investigator, Faculty of Mediicne, University of Novi SadNemanja Gvozdenović, Study director, Faculty of Mediicne, University of Novi Sad; Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655388
- Sponsor's protocol ID
- 00-37/20
- Acronym
- CAP-HIP
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared publicly. Only aggregated and anonymized study results will be published in scientific journals and presented at conferences.
Publications
Tatarusanu SM, Lupascu FG, Profire BS, Szilagyi A, Gardikiotis I, Iacob AT, Caluian I, Herciu L, Gisca TC, Baican MC, Crivoi F, Profire L. Modern Approaches in Wounds Management. Polymers (Basel). 2023 Sep 4;15(17):3648. doi: 10.3390/polym15173648.
PubMed 37688274Liu H, Zhang G, Wei A, Xing H, Han C, Chang Z. Effect of negative pressure wound therapy on the incidence of deep surgical site infections after orthopedic surgery: a meta-analysis and systematic review. J Orthop Surg Res. 2024 Sep 9;19(1):555. doi: 10.1186/s13018-024-05038-7.
PubMed 39252068Garofalo S, Morano C, Bruno L, Pagnotta L. A Comprehensive Literature Review for Total Hip Arthroplasty (THA): Part 2-Material Selection Criteria and Methods. J Funct Biomater. 2025 May 18;16(5):184. doi: 10.3390/jfb16050184.
PubMed 40422848Landen NX, Li D, Stahle M. Transition from inflammation to proliferation: a critical step during wound healing. Cell Mol Life Sci. 2016 Oct;73(20):3861-85. doi: 10.1007/s00018-016-2268-0. Epub 2016 May 14.
PubMed 27180275Masson-Meyers DS, Andrade TAM, Caetano GF, Guimaraes FR, Leite MN, Leite SN, Frade MAC. Experimental models and methods for cutaneous wound healing assessment. Int J Exp Pathol. 2020 Feb;101(1-2):21-37. doi: 10.1111/iep.12346. Epub 2020 Mar 30.
PubMed 32227524
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dressing Type and Dressing Change Frequency on Surgical Wound Healing Following Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07655388
- Acronym / sponsor ID
- CAP-HIP / 00-37/20
- Conditions
- Wound Healing Time, Total Hip Arthroplasty (THA)
- Keywords
- Wound Dressing, VACUTEX, Dressing Change Frequency, Primary Total Hip Arthroplasty, Surgical Wound, Wound Healing, Exudate pH, Wound Temperature
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Clinical Center of VojvodinaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical wound complications following primary total hip arthroplasty remain a significant clinical challenge despite advances in wound care technologies. The optimal choice of dressing and frequency of dressing changes remain insufficiently investigated, particularly regarding their influence on wound healing and the wound microenvironment.
This prospective, randomized, controlled clinical trial aims to evaluate the impact of dressing type and dressing change frequency on surgical wound healing in patients undergoing primary total hip arthroplasty. Ninety patients will be allocated into three treatment groups receiving either a capillary-action dressing system (VACUTEX™) or standard dressings with different dressing change intervals.
The study will assess time to complete wound epithelialization, postoperative wound complications, pain intensity, wound temperature, exudate pH, length of hospital stay, and time to suture removal. In addition, the study will investigate the potential role of wound temperature and exudate pH as early indicators of impaired healing and postoperative complications.
Detailed description
This study will be designed as a prospective, randomized, controlled clinical trial conducted at the Clinic for Orthopedic Surgery and Traumatology, University Clinical Centre of Vojvodina. A total of 90 patients undergoing primary total hip arthroplasty will be enrolled and randomly allocated into three parallel treatment groups using block randomization.
The participants will receive one of the following wound care protocols:
Group 1: VACUTEX™ capillary-action dressing, changed every 4 days until suture removal.
Group 2: Standard dressing with Octenisept® aqueous solution, changed every 3 days until suture removal.
Group 3: Standard dressing with Octenisept® aqueous solution, changed every 2 days until suture removal.
Baseline demographic and clinical data, including age, sex, body mass index (BMI), comorbidities, smoking status, previous orthopedic procedures, and preoperative laboratory parameters (blood glucose, HbA1c, and C-reactive protein), will be collected at admission.
The primary outcome will be time to complete wound epithelialization, defined as the number of days from surgery to complete wound closure without exudate, dehiscence, signs of infection, or need for additional wound interventions.
Secondary outcomes will include:
Incidence of local postoperative wound complications (surgical site infection, dehiscence, seroma, and hematoma according to CDC criteria); Postoperative pain intensity assessed using the Visual Analogue Scale (VAS); Local wound temperature; Wound exudate pH; Length of hospital stay; Time to suture removal. Initial wound assessment will be performed immediately after wound closure in the operating room (postoperative day 0). Subsequent assessments will be conducted at each scheduled dressing change according to the assigned treatment protocol. Wound temperature will be measured using a non-contact infrared thermometer, while exudate pH will be determined using a calibrated digital pH meter. Pain intensity will be evaluated at each assessment using the VAS.
Participants will be followed throughout hospitalization and during outpatient visits up to 30 days after surgery. In cases of wound-related complications, follow-up will be extended up to 90 postoperative days.
Data will be recorded in standardized case report forms and entered into a dedicated database for statistical analysis. Statistical analyses will be performed using IBM SPSS Statistics software. Appropriate parametric and non-parametric tests, repeated-measures analyses, survival analysis (Kaplan-Meier and Cox regression), and multivariable regression models will be used according to the type and distribution of the collected data. A p-value <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VACUTEX™ group | Experimental | Device: VACUTEX™ wound dressingPatients receive wound care using the VACUTEX™ capillary action dressing system with dressing changes performed every 4 days until wound closure (suture removal). |
| Standard dressing - 3-day change | Active comparator | Procedure: Octenisept® wound care dressingPatients receive standard wound care using Octenisept® solution with sterile dressing, with dressing changes performed every 3 days until wound closure (suture removal). |
| Standard dressing - 2-day change | Active comparator | Procedure: Octenisept® wound care dressingPatients receive standard wound care using Octenisept® solution with sterile dressing, with dressing changes performed every 2 days until wound closure (suture removal). |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for primary total hip arthroplasty (THA)
- Age ≥ 65 years
- Ability to provide informed consent
- Patients with closed surgical incision suitable for standard postoperative wound care
Key exclusion criteria (6 listed)
- Revision hip arthroplasty
- Active infection at the time of surgery
- Immunosuppressive therapy or severe immunodeficiency
- Known allergy to dressing materials used in the study
- Severe peripheral vascular disease affecting wound healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VACUTEX™ wound dressingA capillary action-based wound management system designed for continuous removal of exudate without the use of external negative pressure, maintaining a moist wound environment and minimizing dressing adherence to the wound surface. | Device | VACUTEX™ group |
| Octenisept® wound care dressingStandard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management. | Procedure or surgery | Standard dressing - 2-day change, Standard dressing - 3-day change |
Primary outcome
Time to complete wound epithelialization
Time frame: Postoperative day 30 (90 or more in case of wound complications according to CDC criteria)
Time (in days) from surgery to complete wound epithelialization, defined as complete clinical closure of the surgical incision without exudate, dehiscence, or visible wound gaps, as assessed by clinical examination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 37688274Tatarusanu SM, Lupascu FG, Profire BS, Szilagyi A, Gardikiotis I, Iacob AT, Caluian I, Herciu L, Gisca TC, Baican MC, Crivoi F, Profire L. Modern Approaches in Wounds Management. Polymers (Basel). 2023 Sep 4;15(17):3648. doi: 10.3390/polym15173648.
- Background: PubMed 39252068Liu H, Zhang G, Wei A, Xing H, Han C, Chang Z. Effect of negative pressure wound therapy on the incidence of deep surgical site infections after orthopedic surgery: a meta-analysis and systematic review. J Orthop Surg Res. 2024 Sep 9;19(1):555. doi: 10.1186/s13018-024-05038-7.
- Background: PubMed 40422848Garofalo S, Morano C, Bruno L, Pagnotta L. A Comprehensive Literature Review for Total Hip Arthroplasty (THA): Part 2-Material Selection Criteria and Methods. J Funct Biomater. 2025 May 18;16(5):184. doi: 10.3390/jfb16050184.
- Background: PubMed 27180275Landen NX, Li D, Stahle M. Transition from inflammation to proliferation: a critical step during wound healing. Cell Mol Life Sci. 2016 Oct;73(20):3861-85. doi: 10.1007/s00018-016-2268-0. Epub 2016 May 14.
- Background: PubMed 32227524Masson-Meyers DS, Andrade TAM, Caetano GF, Guimaraes FR, Leite MN, Leite SN, Frade MAC. Experimental models and methods for cutaneous wound healing assessment. Int J Exp Pathol. 2020 Feb;101(1-2):21-37. doi: 10.1111/iep.12346. Epub 2020 Mar 30.
- Individual participant dataSharing planned: No. IPD will not be shared publicly. Only aggregated and anonymized study results will be published in scientific journals and presented at conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrijana Ćorić principal investigator
Faculty of Mediicne, University of Novi Sad
Nemanja Gvozdenović study director
Faculty of Mediicne, University of Novi Sad; Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VACUTEX™ wound dressing and Octenisept® wound care dressing in people with Wound Healing Time and Total Hip Arthroplasty (THA), run by Clinical Center of Vojvodina at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrijana Ćorić, MScN (+381611810756, 912007d23@mf.uns.ac.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete wound epithelialization (time frame: Postoperative day 30 (90 or more in case of wound complications according to CDC criteria)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07655388, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.